Challenges
To conduct a cross-sectional, epidemiological study to determine prevalence, disease characteristics, treatment patterns and patient burden of disease to identify the extent of the unmet need, gain data for launch planning and to help determine economic modelling/reimbursement.
Simple study design required due to limited resources at busy dermatology clinics.
Solutions
O4 Research collaborated with the Chief Investigator to develop a final protocol from concept stage.
We created a user friendly CRF to enable real time data entry by the PI who was required to conduct all visits.
Deployment of O4 AccelerateTM and O4 EngageTM enabled robust feasibility, site selection, training and site activation followed by continuous site management support throughout.
The O4 team conducted all data management functions, statistical analysis and preparation of study report in a consolidated period of time to enable the Sponsor to obtain the necessary information to support economic modelling.
Impact
Data was instrumental in helping develop and support an economic model.
Publication in Journal of European Academy of Dermatology and Venereology (EADV).
Oral and poster presentation at EADV Congress.